MAUDE Adverse Event Report: LEESAR, INC. KIMBERLY CLARK; MAJOR BASIN SPONGE PACK

Lot Number 890151

Device Problem Incomplete or Missing Packaging (2312)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/24/2015

Event Type  malfunction  

Event Description

Kimberly clark major basin pack contained only 4 laparotomy sponges instead of 5.

• Brand Name: KIMBERLY CLARK
• Type of Device: MAJOR BASIN SPONGE PACK
• Manufacturer (Section D): LEESAR, INC.; 2727 winkler ave; fort myers FL 33901
• MDR Report Key: 5103780
• MDR Text Key: 26743751
• Report Number: 5103780
• Device Sequence Number: 1
• Product Code: GDY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Report Date: 09/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 04/20/2016
• Device Lot Number: 890151
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/10/2015
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 09/10/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1